{"id":2054,"date":"2019-12-05T07:51:40","date_gmt":"2019-12-05T07:51:40","guid":{"rendered":"https:\/\/bibliography.nanobiotix.com\/?p=2054"},"modified":"2022-05-24T16:59:20","modified_gmt":"2022-05-24T15:59:20","slug":"2019-siog-nbtxr3-for-the-treatment-of-elderly-frail-hnscc-patients","status":"publish","type":"post","link":"https:\/\/bibliography.nanobiotix.com\/fr\/2019-siog-nbtxr3-for-the-treatment-of-elderly-frail-hnscc-patients\/","title":{"rendered":"2019 \u2013 SIOG \u2013 NBTXR3 for the treatment of elderly\/frail HNSCC patients"},"content":{"rendered":"<section class=\"wpb-content-wrapper\"><p>[vc_row padding_top=\u00a0\u00bb0&Prime; padding_bottom=\u00a0\u00bb0&Prime; section_container_layout=\u00a0\u00bbfull-width\u00a0\u00bb remove_horizontal_padding=\u00a0\u00bbyes\u00a0\u00bb module_type=\u00a0\u00bbbg-color\u00a0\u00bb gutter_size=\u00a0\u00bbyes\u00a0\u00bb equal_height=\u00a0\u00bbyes\u00a0\u00bb bg_color=\u00a0\u00bb#28282e\u00a0\u00bb][vc_column][vc_row_inner padding_top=\u00a0\u00bb0&Prime; padding_bottom=\u00a0\u00bb0&Prime; gutter_size=\u00a0\u00bbyes\u00a0\u00bb equal_height=\u00a0\u00bbyes\u00a0\u00bb][vc_column_inner column_paddings=\u00a0\u00bb105&Prime; column_position_vertical=\u00a0\u00bbmiddle\u00a0\u00bb column_min_height=\u00a0\u00bb700&Prime; column_min_height_sm=\u00a0\u00bb400&Prime; column_min_height_xs=\u00a0\u00bb350&Prime; module_type=\u00a0\u00bbbg-image\u00a0\u00bb bg_image=\u00a0\u00bb99&Prime; mask_fx=\u00a0\u00bbyes-mask\u00a0\u00bb mask_color_mode=\u00a0\u00bbpalette\u00a0\u00bb mask_bg_color_palette=\u00a0\u00bbmain-mask\u00a0\u00bb animation_fx=\u00a0\u00bbyes-animation\u00a0\u00bb animation_delay=\u00a0\u00bb200&Prime; animation_offset_scroll_down=\u00a0\u00bb90&Prime; width=\u00a0\u00bb1\/2&Prime; animation_in=\u00a0\u00bbfadeInUp\u00a0\u00bb][vc_empty_space height=\u00a0\u00bb60px\u00a0\u00bb responsive_lg=\u00a0\u00bbhidden\u00a0\u00bb responsive_md=\u00a0\u00bbhidden\u00a0\u00bb][az_box_icons box_icon_title=\u00a0\u00bbAuthors\u00a0\u00bb box_icon_color_mode=\u00a0\u00bbon-the-fly\u00a0\u00bb icon_visibility=\u00a0\u00bbyes-icon\u00a0\u00bb icon_type=\u00a0\u00bbfont\u00a0\u00bb icon=\u00a0\u00bbfa fa-edit\u00a0\u00bb icon_color_mode=\u00a0\u00bbon-the-fly\u00a0\u00bb icon_size=\u00a0\u00bb50&Prime; box_icon_color=\u00a0\u00bb#ffffff\u00a0\u00bb icon_color=\u00a0\u00bb#ffffff\u00a0\u00bb]Christophe Le Tourneau<span class=\"notes up\">1<\/span>, Victor Moreno Garcia<span class=\"notes up\">2<\/span>, Bernard Doger<span class=\"notes up\">2<\/span>, Andrzej Urban<span class=\"notes up\">3<\/span>, Katell Bernois<span class=\"notes up\">3<\/span>, Xavier Liem<span class=\"notes up\">4<\/span>, S\u00e9bastien Salas<span class=\"notes up\">5<\/span>, St\u00e9phanie Wong<span class=\"notes up\">5<\/span>, Nicolas Fakhry<span class=\"notes up\">5<\/span>, Mikaela Dimitriu<span class=\"notes up\">3<\/span>, Valentin Calugaru<span class=\"notes up\">1<\/span>, Caroline Hoffmann<span class=\"notes up\">1<\/span><br \/>\n<span class=\"notes\"><br \/>\n1 \u2013 Institut Curie, Paris, France<br \/>\n2 \u2013 START Madrid, Madrid, Spain<br \/>\n3 \u2013 Nanobiotix, SA ; Paris, France<br \/>\n4 \u2013 Centre Oscar Lambret, Lille, France<br \/>\n5 \u2013 H\u00f4pital Timone, APHM, Marseille, France [\/az_box_icons][vc_empty_space height=\u00a0\u00bb60px\u00a0\u00bb responsive_lg=\u00a0\u00bbhidden\u00a0\u00bb responsive_md=\u00a0\u00bbhidden\u00a0\u00bb][\/vc_column_inner][vc_column_inner column_paddings=\u00a0\u00bb105&Prime; column_position_vertical=\u00a0\u00bbmiddle\u00a0\u00bb module_type=\u00a0\u00bbbg-color\u00a0\u00bb animation_fx=\u00a0\u00bbyes-animation\u00a0\u00bb animation_delay=\u00a0\u00bb300&Prime; animation_offset_scroll_down=\u00a0\u00bb90&Prime; width=\u00a0\u00bb1\/2&Prime; bg_color=\u00a0\u00bb#ffffff\u00a0\u00bb animation_in=\u00a0\u00bbfadeInUp\u00a0\u00bb][vc_empty_space height=\u00a0\u00bb60px\u00a0\u00bb responsive_lg=\u00a0\u00bbhidden\u00a0\u00bb responsive_md=\u00a0\u00bbhidden\u00a0\u00bb][az_box_icons box_icon_title=\u00a0\u00bbSummary\u00a0\u00bb icon_visibility=\u00a0\u00bbyes-icon\u00a0\u00bb icon_type=\u00a0\u00bbfont\u00a0\u00bb icon=\u00a0\u00bbaz-icon az-icon-layers2&Prime; icon_color_mode=\u00a0\u00bbon-the-fly\u00a0\u00bb icon_color=\u00a0\u00bb#28282e\u00a0\u00bb icon_size=\u00a0\u00bb50&Prime;]<strong>Introduction:<\/strong> New therapeutic approaches are needed for elderly or frail head and neck squamous cell carcinoma (HNSCC) patients (pts) ineligible for standard of care. NBTXR3, hafnium oxide nanoparticles injected intratumorally, may represent an option. Otherwise inert, NBTXR3 augments the radiation therapy (RT) dose within tumor cells when activated by RT, increasing tumor cell death compared to RT alone.<\/span><\/p>\n<p><strong>Objectives:<\/strong> The purpose of this Phase I was to evaluate safety (dose limiting toxicity; DLT) and determine the NBTXR3 recommended phase 2 dose (RP2D) in elderly or frail HNSCC pts.<\/p>\n<p><strong>Methods:<\/strong> Eligible pts had stage III or IV HNSCC of oral cavity or oropharynx, were aged \u226570 years or \u226565 years and unable to receive cisplatin but eligible for RT [NCT01946867]. A 3+3 dose escalation design was employed, with NBTRX3 dose levels of 5%, 10%, 15% and 22% of baseline tumor volume. Following intratumoral NBTXR3 injection, pts received IMRT (70 Gy; 35 fractions\/7 weeks). Primary endpoints were RP2D and DLT. Localization of NBTXR3 and preliminary efficacy (RECIST 1.1) were also evaluated.<\/p>\n<p><strong>Results and Conclusion:<\/strong> Dose escalation is complete; 19 pts received NBTXR3: 3 at 5%, 3 at 10%, 5 at 15% and 8 at 22%. No NBTXR3-related DLTs or SAEs were observed. Four related AEs were reported: one AE at 15% (G1 tumor hemorrhage) and 3 AEs at 22% (G2 oral pain; G1 asthenia, G1 injection site hemorrhage). IMRT toxicity was as expected and post-injection CT scan showed NBTXR3 localized within the injected tumor. DSMB determined RP2D to be 22%. Among 13 evaluable pts at doses \u226510%, 9 had a complete response of injected tumor. Results demonstrate that NBTXR3 activated by RT is a well-tolerated therapy with encouraging anti-tumor activity. RP2D expansion is ongoing. NBTXR3 may be an option for elderly or frail pts with locally advanced HNSCC.[\/az_box_icons][vc_empty_space height=\u00a0\u00bb60px\u00a0\u00bb responsive_lg=\u00a0\u00bbhidden\u00a0\u00bb responsive_md=\u00a0\u00bbhidden\u00a0\u00bb][\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]<\/p>\n<\/section>","protected":false},"excerpt":{"rendered":"<p>New therapeutic approaches are needed for elderly or frail head and neck squamous cell carcinoma (HNSCC) patients (pts) ineligible for standard of care. NBTXR3, hafnium oxide nanoparticles injected intratumorally, may represent an option. Otherwise inert, NBTXR3 augments the radiation therapy (RT) dose within tumor cells when activated by RT, increasing tumor cell death compared to RT alone. [\u2026]<\/p>\n","protected":false},"author":1,"featured_media":2057,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[182,183,668],"tags":[193,473,474,196,541,465,475,544,439,342,553,554,583,333,570,200,555],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/2054"}],"collection":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/comments?post=2054"}],"version-history":[{"count":1,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/2054\/revisions"}],"predecessor-version":[{"id":2062,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/posts\/2054\/revisions\/2062"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media\/2057"}],"wp:attachment":[{"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/media?parent=2054"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/categories?post=2054"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bibliography.nanobiotix.com\/fr\/wp-json\/wp\/v2\/tags?post=2054"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}